Establishment of a Prospective Cohort of Mechanically Ventilated Patients

Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2014-005803 on 16 January 2015. Downloaded from Establishment of a prospective cohort of mechanically ventilated patients in ﬁve intensive care units in Lima, Peru: protocol and organisational characteristics of participating centres

Joshua A Denney,1 Francesca Capanni,1 Phabiola Herrera,1 Augusto Dulanto,2 Rollin Roldan,3 Enrique Paz,4 Amador A Jaymez,5 Eduardo E Chirinos,6 Jose Portugal,3 Rocio Quispe,3 Roy G Brower,1 William Checkley,1,7 INTENSIVOS Cohort Study

To cite: Denney JA, ABSTRACT INTRODUCTION et al Capanni F, Herrera P, . Introduction: Mechanical ventilation is a cornerstone Mechanical ventilation has become a main- Establishment of a in the management of critically ill patients worldwide; stay of therapy in the care of critically ill prospective cohort however, less is known about the clinical management of mechanically ventilated patients. Intensive care unit (ICU) practices, of mechanically ventilated patients in low and middle patients in five intensive care mechanical ventilation strategies and their income countries where limitation of resources units in Lima, Peru: protocol social costs in high-income countries (HIC) and organisational including equipment, staff and access to medical information may play an important role in defining are well documented. For example, in characteristics of participating ﬁ 1 centres. BMJ Open 2015;5: patient-centred outcomes. We present the design of a Germany, Chal n calculated that ICU care e005803. doi:10.1136/ prospective, longitudinal study of mechanically comprised 20% of hospital costs. In the USA, 2 bmjopen-2014-005803 ventilated patients in Peru that aims to describe a large Wunsch et al projected that 3% of inpatient cohort of mechanically ventilated patients and identify hospitalisations required mechanical ventila- ▸ Prepublication history for practices that, if modified, could result in improved tion in 2005, comprising 30% of all ICU this paper is available online. patient-centred outcomes and lower costs. admissions and accounting for a dispropor- To view these files please Methods and analysis: Five Peruvian intensive care tionate 12% of all hospital costs. Factors con- http://bmjopen.bmj.com/ visit the journal online units (ICUs) and the Medical ICU at the Johns Hopkins tributing to a higher cost of an individual (http://dx.doi.org/10.1136/ Hospital were selected for this study. Eligible patients bmjopen-2014-005803). ICU stay include sepsis and initiation of were those who underwent at least 24 h of invasive mechanical ventilation.34Despite the higher mechanical ventilation within the first 48 h of Received 29 May 2014 cost and quality of care that an ICU setting admission into the ICU. Information on ventilator Revised 24 November 2014 implies, mortality remains high. In the USA, Accepted 25 November 2014 settings, clinical management and treatment were collected daily for up to 28 days or until the patient studies show that approximately 30% of all was discharged from the unit. Vital status was patients requiring mechanical ventilation die

2 on September 30, 2021 by guest. Protected copyright. assessed at 90 days post enrolment. A subset of before ICU discharge. A Finnish study esti- participants who survived until hospital discharge were mated a 1-year mortality rate of 35% for asked to participate in an ancillary study to assess vital patients receiving more than 6 h of continu- status, and physical and mental health at 6, 12, 24 and ous mechanical ventilation.5 60 months after hospitalisation, Primary outcomes In contrast, less is known in resource include 90-day mortality, time on mechanical limited settings about clinical practices and ventilation, hospital and ICU lengths of stay, and mechanical ventilation strategies used in crit- prevalence of acute respiratory distress syndrome. In ically ill patients.6 Moreover, the burden of subsequent analyses, we aim to identify interventions and standardised care strategies that can be tailored to critical illness in low and middle income resource-limited settings and that result in improved countries (LMICs) is higher than generally patient-centred outcomes and lower costs. perceived and it is expected to increase with 67 et al8 Ethics and dissemination: We obtained ethics an aging population. Esteban ana- For numbered affiliations see approval from each of the four participating hospitals lysed data from 361 ICUs in 20 countries end of article. in Lima, Peru, and at the Johns Hopkins School of across the Americas and Europe, and showed Medicine, Baltimore, USA. Results will be disseminated a statistically signiﬁcant mortality difference as several separate publications in different Correspondence to between the USA, European and Latin Dr William Checkley; international journals. American ICUs for all patients receiving [email protected] mechanical ventilation within a 1-month

Denney JA, et al. BMJ Open 2015;5:e005803. doi:10.1136/bmjopen-2014-005803 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-005803 on 16 January 2015. Downloaded from period, that is, 27% vs 31% vs 34%, respectively. Their stay, mechanical ventilation strategies and selected analysis demonstrates that disparities in mortality rates in aspects of clinical management of critically ill patients the ICUs of varying geographical and socioeconomic requiring at least 24 h of invasive mechanical ventilation status do exist, but did not address what factors may be in five ICUs in Lima, Peru, and in one ICU in the USA contributing to these differences.8 Furthermore, the (figure 1). We further sought to characterise the propor- results from Latin America aggregate data from coun- tion of patients admitted to the ICU with acute respira- tries with varying income levels, which may mask higher tory distress syndrome (ARDS); proportion of patients mortality rates in poorer settings. who developed ARDS while in the ICU; and vital status, ICUs with fewer resources and greater economic lim- physical and mental health at 6, 12, 24 and 60 months itations may have essential differences in delivery of crit- after hospitalisation in a subset of participants. ical care with resulting variations in patient-centred outcomes. These disparities and their effect are not well Outcomes understood.6910Implementation of proven ICU proto- 9 Primary outcomes for this study are 90-day mortality, cols can reduce mortality and costs. Process-driven time on mechanical ventilation, ICU and hospital interventions, such as standardised protocols of care, lengths of stay, and prevalence of ARDS. Additional out- could potentially play a large role in minimising costs comes include vital status at 6, 12, 24 and 60 months for while improving patient outcomes which could be espe- 69 survivors of hospital discharge among participants in cially advantageous in resource-limited settings. Our Peruvian ICUs. A subset of participants will be asked to study focuses on critically ill patients receiving mechan- undergo a follow-up evaluation at 6 months after the fi ical ventilation in LMICs with signi cant resource limita- date of ICU admission to assess the long-term physical tions. Our goal is to better understand best practices in and emotional impact of their hospital stay. resource-limited settings and identify potential changes that could drive significant improvements in outcomes. Study design We present the design of a prospective, longitudinal ‘ ’ cohort of mechanically ventilated patients in Lima, Peru, The INTENSIVOS ( critical in Spanish) cohort is a pro- in five ICUs of public hospitals in Peru and one ICU in spective, observational study. Enrolment began in an academic medical centre in the USA. The study was December 2010 and ended in October 2013. Vital status designed to characterise aetiologies and treatment deci- follow-up and evaluation of physical and mental health sions most frequently seen in mechanically ventilated in a subset of survivors will continue through October patients and their relation to patient-centred outcomes, 2018. This manuscript was written concurrently with the such as 90-day mortality, time on mechanical ventilation, implementation of the protocol and start of this study. and the ICU and hospital lengths of stay. With this infor- At enrolment, we obtained demographic, chronic mation, we aim to identify best practices and standardised disease and acute physiological data for all patients http://bmjopen.bmj.com/ care strategies that can be tailored to resource-limited set- meeting the eligibility criteria. They were followed daily tings and applied in the future in the ICUs to improve to monitor vital status, clinical and ventilator manage- patient-centred outcomes and lower costs. ment, acute physiology and use of sedation during their ICU stay for up to 28 days in the ICU, until ICU discharge or death. Patients successfully discharged from METHODS the ICU were followed for vital status during their Study objectives inpatient hospital stay. All patients were contacted

We sought to characterise 90-day mortality, time spent at 90 days after enrolment to assess their vital status. on September 30, 2021 by guest. Protected copyright. on mechanical ventilation, ICU and hospital lengths of A subset of participants who survived until hospital

Figure 1 Flowchart of participating intensive care units (ICU).

2 Denney JA, et al. BMJ Open 2015;5:e005803. doi:10.1136/bmjopen-2014-005803 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-005803 on 16 January 2015. Downloaded from discharge were asked to participate in an ancillary study on a daily basis and an ICU physician (co-investigator) and undergo a battery of tests to assess physical and supervised the data collection and was responsible for mental health after hospitalisation. We aim to include data quality, review of clinical and ventilator data, and 150 participants. Long-term outcomes will include vital interpretation of the chest X-rays (CXR). In addition, a status at 6, 12, 24 and 60 months, lung function, 6 min team of two study physician coordinators from the walk test, handgrip strength, respiratory symptoms, pres- Clinical and Data Coordinating Center (DCC) oversaw ence of anxiety or post-traumatic stress disorder (PTSD), the day-to-day operations of the study and acted as and depression. The instruments used to evaluate these the liaison between the principal investigator and outcomes include the Hospital Anxiety and Depression co-investigators. The DCC is composed of team Scale,11 the European Quality of Life 5 Dimensions 5 members located in Peru and the USA. Study physician Levels Classification System,12 the Pittsburgh Sleep coordinators visited each ICU on an average of 2–3 Quality Index,13 the Impact of Event Scale—Revised,14 times a week to verify data accuracy and fidelity along the Telephone Interview for Cognitive Status,15 the with co-investigators and study nurses, perform range 36-item short-form health survey,16 and the Katz and checks and to obtain an electronic copy of CXRs. Lawton-Brody Activities of Daily Living Scale. Incomplete or incorrectly entered case report forms (CRFs) were returned to study nurses for revision of fl Eligibility criteria missing or agged data. Data forms were collected from Eligibility criteria were: (1) age >18 years, (2) at least all ICUs on a weekly basis and transferred to the DCC fi 24 h of invasive mechanical ventilation in one of the of ce in Peru for double data entry into a centralised ICUs participating in the study and (3) enrolment into database. The DCC data manager also conducted a the study within 48 h of onset of mechanical ventilation. careful review, and incomplete or incorrectly entered CRFs were returned to the study physician coordinators, who reviewed the missed or flagged data with the Study sites co-investigators and study nurses. Finally, a DCC nurse The study was conducted in five ICUs at four public hos- was responsible for follow-up telephone calls to assess pitals of the Social Security System (ESSALUD) and 90-day vital status and to invite participants to join the Ministry of Health (MINSA) in Lima, Peru, and in the long-term outcomes ancillary study among survivors. Medical ICU (MICU) of Johns Hopkins Hospital ( JHH; figure 2). We included only one ICU per hospital with the exception of Hospital Rebagliati, for which we Case report forms included two ICUs. Participating ICUs were selected on CRFs were modelled on the forms used by ARDS the basis of high case volume and willingness to partici- Network trials with additional fields added to capture 17 pate. A 4-week test period was initially carried out at the Charlson comorbidity index, Acute Physiology And http://bmjopen.bmj.com/ each hospital in Peru to determine feasibility and Chronic Health Evaluation (APACHE) II (A2F),18 monthly case volume. Of the six hospitals evaluated in APACHE III (A3F),19 Multiple Organ Dysfunction Score Peru, two were unable to meet established a priori (MODS),20 Mortality Probability Admission Model III requirements during the test period and were not (MPM)21 and Sequential Organ Failure Assessment invited to continue in the study. (SOFA) (SOF) scores.22 The CRFs were designed to capture demographic and chronic health information at Study team baseline and daily information on acute physiology,

Data collection and quality control was organised using selected aspects of clinical management, mechanical on September 30, 2021 by guest. Protected copyright. a tiered approach. At each ICU, a team of 2–7 study ventilation and weaning practices, and sedation manage- nurses were responsible for paper-based data collection ment. Forms were originally written in English,

Figure 2 Sequence of data submission (ICU, intensive care unit; PCF, Patient Contact Form; BCI, Baseline Clinical Form; DCI, Daily Clinical Form; CXR, chest X-ray form; SEF, Sepsis Evaluation Form; AFF, ARDS follow-up form; STF, Study Termination Form; 6MWT, 6 min walk test; PTSD, post-traumatic stress disorder).

Denney JA, et al. BMJ Open 2015;5:e005803. doi:10.1136/bmjopen-2014-005803 3 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-005803 on 16 January 2015. Downloaded from translated into Spanish and then translated back into associated pneumonia, gastrointestinal ulcers and English to confirm accuracy of translation. venous thromboembolism, lung protective ventilation, Prior to start of the study, the study team underwent transfusion practices, use of central lines, arterial cath- an inperson training session on how to accurately record eter and pulmonary artery catheters), mechanical data in paper-based CRFs. Inperson training sessions ventilation management (mode of ventilation, tidal were repeated approximately every 6 months during the volume, airway pressures, oxygenation and positive first 2 years. All study team members were provided with end-expiratory pressure) and use of medications such as a manual of operations with instructions on how to vasopressors, medications for prophylaxis for prevention accurately fill the forms. These forms were completed in of gastrointestinal ulcers and venous thromboembolism, black or blue ink, reviewed by co-investigators and study opioids, benzodiazepines, sedatives, neuromuscular physician coordinators and then transferred to the DCC blockers, antipsychotics and antibiotics. DCIs were com- where they were double-data entered into a centralised pleted daily for the first 28 days or until patients died or database. The CRFs were: a Patient Contact Form (PCF), were discharged from the ICU. Data for the DCI was Baseline Clinical Information Form (BCI), Daily Clinical captured over a defined 24 h period of time. To ensure Information Form (DCI) and a Study Termination Form that data was captured only once it was necessary to (STF). Paper-based worksheets to calculate ICU severity create an arbitrary 24 h period (ie, a study day). A study scores such as A2F, A3F, MPM and SOF were also pro- day was defined as the 24 h prior to 8:00 on the day of vided to the study team. Two additional forms were data collection. Participating hospitals were instructed to added later on and are available to a subset of study par- enter data for each DCI using values obtained as close ticipants: ARDS follow-up form, in which study team as possible to 08:00. members record additional ventilator parameters during The STF was used to record 90-day mortality and the first 7 days after onset in patients who met criteria other ICU milestones, such as time on mechanical venti- for ARDS; and Sepsis Evaluation Form, which recorded lation, dates of tracheostomy placement, and ICU and additional clinical parameters associated with sepsis hospital discharge. In-hospital deaths were also during the first 14 days after enrolment. recorded. Patients were followed throughout their hos- The PCF included patient information such as name, pital stay after ICU discharge to determine date of hos- date of birth, address and telephone contact informa- pital discharge or death. Vital status was assessed on the tion for determination of follow-up of vital status after STF at 15, 30, 45, 60 and 90 days after initiation of mech- hospital discharge. This is the only form that contained anical ventilation. After hospital discharge, vital status protected patient information linked to a corresponding was obtained via a telephone call at 90 days and at subse- unique participant identification code (PID) in the quent dates as part of the long-term outcomes substudy. study. The PCFs were stored in locked cabinets and the Although participating ICUs in Peru are in the electronic database was only available to the DCC data process of acquiring the necessary infrastructure for http://bmjopen.bmj.com/ manager and to the nurse in charge of follow-up tele- electronic medical records, none currently have it in phone calls. To complete the subsequent forms pertain- place. Thus, data collectors manually recorded all data ing to a specific patient, the PID was transcribed exactly in paper-based forms. Although the CRFs have a section as it appeared on the PCF. PIDs were checked daily by to record CXR findings, digital copies of all correspond- ICU team members for verification of their accuracy. ing CXRs were also obtained and stored. The PCFs for individual patients served as the only link between medical information and patient identifying Sample size information, and will be destroyed on completion of the Enrolment spanned a period of 3 years. We aimed to on September 30, 2021 by guest. Protected copyright. study. enrol at least 300 patients at each participating ICU for The BCI was completed on patient admission to the a total of 1800 participants across all six ICUs. ICU. If a patient was readmitted to the ICU, a new BCI was filled. The BCI collected information in the first Characteristics of participating ICUs 24 h of mechanical ventilation The BCI also recorded The five Peruvian ICUs that took part in this study were height, chronic health information and acute physiology from four public Peruvian hospitals of varying size and data. Height was measured using a standardised sources of funding; thus, there are some differences approach while in supine position. The BCI also had between the number of beds and influx of patients screening criteria for ARDS, modelled after that used by between units (table 1). Hospital Rebagliati, the site of the ARDS Network, to assess whether or not a patient two participating ICUs, is the largest centre with over had ARDS on enrolment. 1500 beds and more than 55 000 yearly admissions. The DCI was collected daily, considering day 0 as the Hospital Nacional Almenara and Hospital Nacional first 24 h of mechanical ventilation. It consisted of daily Loayza are similar in size, both with approximately 800 laboratory tests (complete blood count, comprehensive beds and 2500 yearly admissions. Hospital Casimiro metabolic panel, arterial blood gas results), selected Ulloa is the smallest centre with only 76 beds; however, aspects of clinical management (fluid management, this is a Trauma and Emergency Medicine centre and delirium management, prevention of ventilator- thus, the number of emergency department visits and

4 Denney JA, et al. BMJ Open 2015;5:e005803. doi:10.1136/bmjopen-2014-005803 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-005803 on 16 January 2015. Downloaded from

yearly admissions are much higher than would be expected for a hospital of this size. Reported annual ICU mortality for all ICUs was quite similar, ranging from 16.7% to 22.9%, and average annual ICU mortality is similar to that of the JHH MICU.

ICU organisation and structure Johns Hopkins Hospital The ﬁve ICUs in Peru also have several structure-related (table 2) and process-related factors (table 3)in common. They are all closed ICUs with a 24 h, in-hospital attending intensivist coverage (vs the high-intensity, only daytime coverage model at JHH MICU), and with a vari- able number of critical care fellows and residents

Hospital Casimiro Ulloa depending on the size of the teaching programme. The Peruvian ICUs average a ratio of 2 beds per nurse (ranging from 1.3:1 to 3:1) and there are physician assistants or nurse practitioners in the ICU as in the JHH MICU. A notable difference between the Peruvian ICUs and the JHH MICU is the absence of respiratory therapists in the former. Since there are no established ventila- Hospital Nacional Loayza tion protocols in use at the Peruvian ICUs, ventilator settings are based on intensivist preference. Delirium assessment is not commonly practiced by ICU nurses in Peru whereas this is the standard of care at the JHH MICU. Finally, the daily goals of care checklist is incon- sistently used across participating ICUs in Peru. Another difference between the Peruvian ICUs and JHH MICU is the presence of a multidisciplinary team during rounds (table 3). Medical rounds in the Peruvian Hospital Nacional Rebagliati (ICU-7) ICUs were comprised only of physicians (attending intensivists, residents and fellows). Nurses do not do the round with the medical staff and instead, do their own rounds during shift change. Also, there are no pharma- http://bmjopen.bmj.com/ cists, physical therapists, social workers, nutritionists or palliative care specialists present during the rounds. The main communication between nursing and medical staff occurs once a day during a meeting between the attend-

Hospital Nacional Rebagliati (ICU-2) ing physician and charge nurse. Finally, Peruvian ICUs do not have electronic patient records or computerised order entry systems as does the JHH MICU. on September 30, 2021 by guest. Protected copyright.

DISCUSSION This study is designed to characterise patient outcomes and clinical practices in mechanically ventilated patients

Hospital Nacional Almenara in ﬁve Peruvian ICUs located at four public hospitals, and to compare this with patients that have a similar dis- tribution in age, sex and severity of illness in an academic medical centre in the USA and if possible, also with patients enrolled in contemporary multicentre studies. Speciﬁc patient-centred outcomes include 90-day mortality, time on mechanical ventilation, length of ICU and hospital stay, and prevalence of ARDS. Selected aspects of clinical management include ventila- Hospital characteristics and utilisation tor management, sedation management and use of laboratory data to drive clinical decision-making among

Annual ICU mortality (%)Type of hospitalTeaching hospitalCritical care training programmeRapid response teamElectronic 19.9 patient record YesComputerised order entryAdult beds at hospital PublicAdult Yes (ESSALUD) ICU beds at hospitalAdult Yes No step down No beds atPaediatric hospital ICU Public beds (ESSALUD) at hospitalBeds in 20.4 study ICU 80 Yes 60Annual 12 950 ED visitsAnnual hospital admissions Public (ESSALUD)Annual study ICU Yes admissions No No No 30 000 300 21 Public (MINSA)other 114 22.9 1526 140 69 000 9 Yes Public (MINSA) preventive Private, non 55 for 750 Yes profit 386 No 24 No 225 No 300strategies 114 1526 18.1 69 Yes 9 commonly 55 750 Yes 225 300 386 No 16.7 No 11 No used Yes 12 800 in 13 Yes critical 2685 10 19 No 71 No 660 Yes No 200 76 6 8 Yes 16 3800 0 93 000 Yes Yes Yes 580 854 54 11 48 487 84 100 892 80 900 24 Table 1 Hospital characteristics Number of beds Utilisation ED, emergency department; ESSALUD, Peruvian Social Security System; ICU, intensive care unit; MINSA, Peruviancare. Ministry of Health. We hypothesise that signiﬁcant differences exist in

Denney JA, et al. BMJ Open 2015;5:e005803. doi:10.1136/bmjopen-2014-005803 5 6 pnAccess Open

Table 2 ICU staffing and organisation Hospital Nacional Hospital Nacional Hospital Nacional Hospital Nacional Hospital Casimiro Johns Hopkins Almenara Rebagliati (ICU-2) Rebagliati (ICU-7) Loayza Ulloa Hospital ICU staffing Intensivist in ICU Yes Yes Yes Yes Yes Yes 24/7 intensivist Yes Yes Yes Yes Yes No Leapfrog compliant? Yes Yes Yes Yes Yes Yes Number of ICU fellows 4 3 2 3 1 2 24/7 ICU fellow 2 0 0 1 0 No Number of ICU residents 4 1 1 6 1 10 Number of respiratory therapists in ICU 0 0 0 0 0 2 Number of ICU nurses 7 11 5 6 4 11 Ratio of beds to nurses 3:1 2.2:1 2.2:1 1.3:1 2.8:1 1.8:1 Number of physician assistants 0 0 0 0 0 3 Number of nurse practitioners 0 0 0 0 0 4 Charge nurse provides patient care? Yes Yes Yes Yes Yes Yes ICU Organisation Closed unit Yes Yes Yes Yes Yes Yes Has medical director Yes Yes Yes Yes Yes Yes Has nurse manager Yes Yes Yes Yes Yes Yes Has clinical nurse specialist No No No No No Yes Continuous renal replacement therapy in ICU Yes No No No No Yes enyJA, Denney ICU, intensive care unit; RT, respiratory therapist. tal et . M Open BMJ Table 3 Process-related factors in participating ICUs Hospital Nacional Hospital Nacional Hospital Nacional Hospital Hospital Johns Hopkins

2015; Almenara Rebagliati (ICU-2) Rebagliati (ICU-7) Nacional Loayza Casimiro Ulloa Hospital ICU rounding practices 5 e083 doi:10.1136/bmjopen-2014-005803 :e005803. Pharmacist on rounds No No No No No Yes Respiratory therapist on rounds No No No No No Yes Physical therapist on rounds No No No No No Yes Social worker on rounds No No No No No No Nutritionist on rounds No No No No No No Palliative care on rounds No No No No No No Delirium assessment by nursing No No No No No Yes Daily goals of care checklist Yes No No No Yes Yes Daily meeting between physician Yes Yes Yes Yes Yes Yes and charge nurse Median number of protocols 0 0 0 0 0 19

ICU, intensive care unit.

BMJ Open: first published as 10.1136/bmjopen-2014-005803 on 16 January 2015. Downloaded from from Downloaded 2015. January 16 on 10.1136/bmjopen-2014-005803 as published first Open: BMJ http://bmjopen.bmj.com/ on September 30, 2021 by guest. Protected by copyright. by Protected guest. by 2021 30, September on Open Access BMJ Open: first published as 10.1136/bmjopen-2014-005803 on 16 January 2015. Downloaded from the management of mechanically ventilated patients in Fourth, we were limited by budget to collect prospective LMICs and that these differences result in an increased data from only one academic medical centre in the USA. mortality and a longer length of stay even when adjusted Nonetheless, we will also have the opportunity to compare for severity. We aim to identify best practices and stan- clinical outcomes with those in contemporary multicentre dardised care tailored to resource-limited settings that studies.38 39 Finally, caution will be needed in applying the may result in improved patient-centred outcomes. results to other LMICs because of differences in health- While international comparisons can be notoriously care delivery and medical education. difficult because of inherent differences in admission criteria and discharge practices across countries, we speculate that critical care performed in resource- CONCLUSIONS limited settings will most likely show negative effects on This study represents a large initiative to establish a patient-centred outcomes. Much of these negative network of ICUs in Peru and understand selected aspects effects are likely to be driven by limitations of resources. of clinical management and patient-centred outcomes of What is not known is the degree to which these limita- mechanically ventilated patients. We aim to identify poten- tions affect patient-centred outcomes and which specific tial aspects of clinical care that can be improved to reduce treatments or interventions are most responsible for mortality and decrease length of stay at participating ICUs. these differences. Reasons for the expected disparity in The implementation of best practices in resource-limited patient-centred outcomes between LMIC and HIC are settings could provide important benefits to patients but likely to be multifactorial. also reduce costs. In general, as the economy of any What is thought to constitute best practices in critical country improves, a larger portion of that country’s care around the world and what can be effectively trans- resources will be diverted towards healthcare and thus, lated to resource-limited settings? Several critical care critical care medicine will become more sophisticated. – societies and organisations23 27 have assembled guide- This study aims to identify clinical practices that may best lines to help direct and standardise care of critically ill explain observed differences in patient-centred outcomes. patients. Standardisation of care can be either structure If the causative agents for major differences in mortality (ie, conditions under which patient care is provided) or are isolated, protocols directed at their mitigation could process related (ie, activities that constitute patient care). result in maximising lives saved per dollar allocated. Structure-related factors, such as availability of nurse and fi fi Author affiliations ancillary medical staf ng, are generally more dif cult to 1Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins implement. For example, Peru does not have respiratory University, Baltimore, USA therapy practitioners and ventilator management is done 2Biomedical Research Unit, Asociación Benéfica PRISMA, Lima, Peru 3 by residents and attending physicians. Moreover, lack of Servicio De Cuidados Intensivos, Hospital Nacional Edgardo Rebagliati

Martins, Lima, Peru http://bmjopen.bmj.com/ ancillary services, such as social workers and other posta- 4 ﬁ Servicio De Cuidados Intensivos, Hospital Nacional Guillermo Almenara cute services, may have a signi cant impact on patient- Irigoyen, Lima, Peru centred outcomes, such as length of stay. Process-related 5Servicio De Cuidados Intensivos, Hospital Nacional Arzobispo Loayza, Lima, factors may allow for cost-effective interventions through Peru 6 standardisation of clinical management. There is strong Servicio De Cuidados Intensivos, Hospital De Emergencias José Casimiro Ulloa, Lima, Peru evidence-based support of process-based interventions, 7Program in Global Disease Epidemiology and Control, Department of such as low tidal volumes for lung protective ventila- International Health, Bloomberg School of Public Health, Johns Hopkins 28 29 30 31 tion, restrictive blood transfusion practices, early University, Baltimore, USA

32 33 ﬂ on September 30, 2021 by guest. Protected copyright. goal-directed therapy, conservative uid manage- Twitter Follow Amador Jaymez at @aljayva ment strategies,34 and standardised sedation manage- 35 36 Collaborators Other members of the INTENSIVOS Cohort Study: Maria ment and weaning protocols. However, potential Alejandra Caravedo (AB PRISMA), Jorge Cerna (Hospital Rebagliati), Long challenges exist with implementation of process-related Davalos (AB PRISMA), Aldo De Ferrari ( Johns Hopkins University), Maria factors, such as common practices and beliefs, that are Alejandra Pereda (AB PRISMA), Nicole Mongilardi ( Johns Hopkins institution or country speciﬁc. University), Navid Shams ( Johns Hopkins University), Carmen Paredes Our study has some potential shortcomings. While the (AB PRISMA). CRFs implemented in this study are exhaustive, we were Contributors JAD and FC were equally responsible for writing of the unable to collect information on standardised evaluation manuscript and participated in study design and conduct. PH, AD, RR, EP, tools for delirium, such as Confusion Assessment Method AAJ, EEC, JP and RQ participated in study design and conduct, and assisted 37 in writing of the manuscript. RB provided expert guidance in the design and ICU, which are not used in Peruvian ICUs. Second, conduct of this study and assisted in writing of the manuscript. WC given that our study extends over a period of 3 years, our conceived the study and had ultimate oversight for the design and conduct, observational study may potentially lead to changes in clin- and writing of this manuscript. ical practice (ie, Hawthorne effect) based on the types of Funding This study was supported by a Pathway to Independence Award questions that were asked in our CRFs. Third, some infor- (R00HL096955) from the National Heart, Lung and Blood Institute, United mation will only be available in subsets of data because not States National Institutes of Health. Publication of this article was funded by all patients had daily or even weekly laboratory data col- the Open Access Promotion Fund of the Johns Hopkins University Libraries. lected due to resource limitations at our Peruvian ICUs. Competing interests None.

Denney JA, et al. BMJ Open 2015;5:e005803. doi:10.1136/bmjopen-2014-005803 7 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-005803 on 16 January 2015. Downloaded from

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8 Denney JA, et al. BMJ Open 2015;5:e005803. doi:10.1136/bmjopen-2014-005803